ALENDRONATE-CHOLECALCIFEROL TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE); VITAMIN D3 (CHOLECALCIFEROL)

から入手可能:

FROSST A DIVISION OF MERCK CANADA INC

ATCコード:

M05BB03

INN（国際名）:

ALENDRONIC ACID AND CHOLECALCIFEROL

投薬量:

70MG; 2800UNIT

医薬品形態:

TABLET

構図:

ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) 70MG; VITAMIN D3 (CHOLECALCIFEROL) 2800UNIT

投与経路:

ORAL

パッケージ内のユニット:

4

処方タイプ:

Prescription

治療領域:

VITAMIN D

製品概要:

Active ingredient group (AIG) number: 0251575001; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2016-05-05

製品の特徴

_ALENDRONATE-CHOLECALCIFEROL _
_(alendronate sodium/cholecalciferol)_
PRODUCT MONOGRAPH
ALENDRONATE-CHOLECALCIFEROL 70/2800
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 70 MCG CHOLECALCIFEROL (2800 IU VITAMIN D
3
)
ALENDRONATE-CHOLECALCIFEROL 70/5600
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 140 MCG CHOLECALCIFEROL (5600 IU VITAMIN D
3
)
Bone Metabolism Regulator and Vitamin D
FROSST, A DIVISION OF MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
DATE OF REVISION:
APRIL 25, 2016
www.merck.ca
SUBMISSION CONTROL NO:
193513
_ALENDRONATE-CHOLECALCIFEROL _
_(alendronate sodium/cholecalciferol)_
_Page 2 of 44_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT INFORMATION
.......................................................................3
INDICATIONS AND CLINICAL USE
.............................................................................3
CONTRAINDICATIONS
..................................................................................................4
WARNINGS AND PRECAUTIONS
.................................................................................4
ADVERSE
REACTIONS....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND
STABILITY..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...................